This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

67029 

Vol. 75, No. 210 

Monday, November 1, 2010 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 748 

[Docket No. 101006492–0494–02 ] 

RIN 0694–AF02 

Amendment to Existing Validated EndUser Authorization in the People’s 

Republic of China: Semiconductor 

Manufacturing International 

Corporation 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: In this action, the Bureau of 

Industry and Security (BIS) amends the 

Export Administration Regulations 

(EAR) to remove one facility from the 

list of Semiconductor Manufacturing 

International Corporation (SMIC) 

facilities that are authorized to receive 

certain items in the People’s Republic of 

China (PRC) under SMIC’s validated 

end-user (VEU) authorization. 

Specifically, BIS removes Cension 

Semiconductor Manufacturing 

Corporation (Cension) from SMIC’s list 

of approved VEU facilities in the PRC 

due to a material change at SMIC. This 

amendment is not the result of 

prohibited activities by Cension or by 

SMIC, nor does it establish any new 

license requirements or more restrictive 

licensing policies for exports, reexports 

or transfers (in-country) of items to the 

facility identified in this rule; license 

requirements set forth in the EAR 

continue to apply to this facility. 

DATES: This rule is effective November 

1, 2010. Although there is no formal 

comment period, public comments on 

this regulation are welcome on a 

continuing basis. 

ADDRESSES: You may submit comments, 

identified by RIN 0694–AF02 by any of 

the following methods: 

E-mail: publiccomments@bis.doc.gov. 

Include ‘‘RIN 0694–AF02’’ in the subject 

line of the message. 

Fax: (202) 482–3355. Please alert the 

Regulatory Policy Division, by calling 

(202) 482–2440, if you are faxing 

comments. 

Mail or Hand Delivery/Courier: Sheila 

Quarterman, U.S. Department of 

Commerce, Bureau of Industry and 

Security, Regulatory Policy Division, 

14th Street & Pennsylvania Avenue, 

NW., Room 2705, Washington, DC 

20230, Attn: RIN 0694–AF02. 

Send comments regarding the 

collection of information associated 

with this rule, including suggestions for 

reducing the burden, to Jasmeet Seehra, 

Office of Management and Budget 

(OMB), by e-mail to 

Jasmeet_K._Seehra@omb.eop.gov or by 

fax to (202) 395–7285. Comments on 

this collection of information should be 

submitted separately from comments on 

the final rule (i.e., RIN 0694–AF02)—all 

comments on the latter should be 

submitted by one of the three methods 

outlined above. 

FOR FURTHER INFORMATION CONTACT: 

Karen Nies-Vogel, Chairman, End-User 

Review Committee, Bureau of Industry 

and Security, U.S. Department of 

Commerce, 14th Street & Pennsylvania 

Avenue, NW., Washington, DC 20230; 

by telephone (202) 482–3811, or by 

e-mail to kniesv@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Authorization Validated End-User 

Consistent with U.S. Government 

policy to facilitate trade for civilian endusers in the PRC, on June 19, 2007 BIS 

amended the EAR in a final rule (72 FR 

33646) to create a new authorization to 

allow ‘‘validated end-users’’ (VEUs) 

located in eligible destinations to 

receive certain items through export, 

reexport or transfer (in-country) under a 

general authorization rather than 

requiring a license. 15 CFR 748.15. 

Companies listed as VEUs may obtain 

eligible items that are on the Commerce 

Control List, set forth in Supplement 

No. 1 to part 774 of the EAR, without 

having to wait for their suppliers to 

obtain export licenses from BIS. Eligible 

items may include commodities, 

software and technology, except for 

those items that are controlled for 

missile technology or crime control 

reasons. 

Authorization VEU is a mechanism to 

facilitate increased high-technology 

exports to companies in eligible 

destinations that have a verifiable 

record of civilian uses for such items. 

The validated end-users listed in 

Supplement No. 7 to Part 748 of the 

EAR were reviewed and approved by 

the U.S. Government in accordance with 

the provisions of Section 748.15 and 

Supplement Nos. 8 and 9 to Part 748 of 

the EAR. In addition to U.S. exporters, 

Authorization VEU may be used by 

foreign reexporters and persons 

transferring in-country, and does not 

have an expiration date. Currently, 

VEUs are located in the PRC and India. 

Removal of Cension Semiconductor 

Manufacturing Corporation (Cension) 

From the List of Validated End-User 

Semiconductor Manufacturing 

International Corporation’s (SMIC’s) 

Approved Facilities in the PRC 

In a rule published in the Federal 

Register on October 19, 2007 (72 FR 

59231), BIS designated SMIC as a VEU, 

thus authorizing certain specific 

exports, reexports and transfers (incountry) to the five listed facilities of 

the company, including Cension. Due to 

a material change at the Cension facility 

of SMIC, and consistent with section 

748.15 of the EAR, BIS now amends 

Supplement No. 7 to Part 748 of the 

EAR to remove the Cension facility from 

that list of SMIC’s approved VEU 

facilities. This change leaves four SMIC 

facilities that are approved to receive 

eligible items under SMIC’s VEU 

authorization. Cension’s address (i.e., 

3/F, 8–1 Kexin Road, Export Processing 

Zone (West Area), Chengdu, China 

611731) will also be removed from the 

list of SMIC’s authorized VEU facilities. 

As a result of this rule, the Cension 

facility will no longer be authorized to 

receive items through Authorization 

VEU. Thus, parties seeking to export, 

reexport or transfer (in-country) items 

under the EAR to the Cension facility 

may now have to obtain a license to do 

so, depending on the item at issue. 

This amendment is not the result of 

prohibited activities by Cension or 

SMIC. SMIC remains a qualified 

participant in the VEU program and 

exports, reexports and transfers (incountry) of the items controlled under 

the export control classification 

numbers listed in SMIC’s entry in 

Supplement No. 7 to Part 748 of the 

mstockstill on DSKH9S0YB1PROD with RULES

67030 Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Rules and Regulations 

EAR to the SMIC facilities listed in the 

same part may continue to be made 

under Authorization VEU. Nor does this 

action establish any new license 

requirements, or more restrictive 

licensing policies, for exports, reexports 

or transfers (in-country) of items to the 

Cension facility. Rather, the license 

requirements set forth in the EAR 

continue to apply to this facility. 

Note that this amendment applies 

only to transactions under 

Authorization VEU involving SMIC’s 

Cension facility. All conditions and 

restrictions that applied to transactions 

that were undertaken pursuant to 

Authorization VEU prior to the effective 

date of this amendment, and that 

involve the Cension facility, continue to 

apply to those transactions. These 

restrictions and conditions include any 

that were imposed on this facility in 

connection with its eligibility for 

Authorization VEU, as established by 

BIS in its communications authorizing 

the Cension facility’s participation in 

the VEU program. 

Saving Clause 

Shipments of items removed from 

eligibility for export, reexport or transfer 

(in-country) under Authorization VEU 

(i.e., under the designator VEU) as a 

result of this regulatory action that were 

on dock for loading, on lighter, laden 

aboard an exporting carrier, or en route 

aboard a carrier to a port of export, on 

November 1, 2010, pursuant to actual 

orders for export, reexport or transfer 

(in-country) to an eligible destination, 

may proceed to that destination under 

the previously applicable Authorization 

so long as they are exported, reexported 

or transferred (in-country) before 

November 16, 2010. Any such items not 

actually exported, reexported or 

transferred (in-country) before midnight, 

on November 16, 2010, require an 

individual license or other applicable 

authorization under the EAR. 

Since August 21, 2001, the Export 

Administration Act has been in lapse 

and the President, through Executive 

Order 13222 of August 17, 2001 (3 CFR, 

2001 Comp., p. 783 (2002)), as extended 

most recently by the Notice of August 

12, 2010 (75 FR 50681) (August 16, 

2010), has continued the EAR in effect 

under the International Emergency 

Economic Powers Act. BIS continues to 

carry out the provisions of the Act, as 

appropriate and to the extent permitted 

by law, pursuant to Executive Order 

13222. 

Rulemaking Requirements 

1. This final rule has been determined 

to be not significant for the purposes of 

Executive Order 12866. 

2. This rule involves information 

collections previously approved by 

OMB under control number 0694–0088, 

‘‘Multi-Purpose Application’’ (Form BIS 

748). This collection has a burden hour 

estimate of 58 minutes for the 

preparation and submission of the form, 

and an estimated burden of 30 minutes 

per submission for recordkeeping, 

reporting and review requirements in 

connection with the Authorization VEU 

program. Although this rule may result 

in a slight increase in license 

applications, this rule is not expected to 

impact the information collection 

request previously approved by OMB 

under control number 0694–0088. 

Notwithstanding any other provisions 

of law, no person is required to respond 

to nor be subject to a penalty for failure 

to comply with a collection of 

information, subject to the requirements 

of the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.) (PRA), unless 

that collection of information displays a 

currently valid OMB Control Number. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined under Executive Order 

13132. 

4. There is good cause under 5 U.S.C. 

553(b)(B) to waive the provisions of the 

Administrative Procedure Act (APA) 

requiring prior notice and the 

opportunity for public comment 

because, specific to this rule, they are 

unnecessary, impracticable and contrary 

to the public interest. 

In determining whether to grant or 

revoke validated end-user designations, 

a committee of U.S. Government 

agencies evaluates a variety of 

information, the nature and terms of 

which are set forth in 15 CFR part 748, 

Supplement No. 8. The criteria for 

evaluation by the committee are set 

forth in 15 CFR 748.15(a)(2). The 

information, commitments and criteria 

for this extensive review were all 

established through the notice of 

proposed rulemaking and public 

comment process (71 FR 38313, July 2, 

2006 and 72 FR 33646, June 19, 2007). 

Thus, authorization of a VEU is similar 

to granting a license: To receive 

Authorization VEU, an application must 

be submitted on behalf of an entity; the 

entity must be found to meet certain 

previously identified criteria; and the 

application must be approved. Because 

the authorization granted by BIS 

pursuant to 15 CFR § 748.15 is similar 

to that granted to exporters for 

individual licenses, which do not 

undergo public review when they are 

approved, denied, revoked, or amended, 

allowing public review and comments 

to this rule is unnecessary. 

The procedure for revocation of a 

facility from the Authorized VEU list is 

similar to the license revocation 

procedure, and because this rule 

involves revocation, public comment on 

it is unnecessary. During the revocation 

procedure, the U.S. Government 

analyzes confidential business 

information according to set criteria to 

determine whether a given authorized 

VEU entity remains eligible for VEU 

status. Revocation may, as in this case, 

be the result of a material change in 

circumstance at the authorized facility. 

Examples of such a material change 

include changes in the operational 

status of a VEU facility or changes in the 

end-use of the products produced at the 

facility. Such changes may result in a 

VEU or a VEU facility no longer meeting 

the eligibility criteria for Authorization 

VEU, and thus may lead the U.S. 

Government to modify or revoke VEU 

authorization. Facilities that undergo 

material changes that result in their no 

longer meeting the criteria to be eligible 

VEUs must, according to the VEU 

program, have their VEU status revoked. 

Here, the Cension facility is no longer 

eligible to be an Authorized VEU, and 

so, by the terms of the EAR and the VEU 

program, the facility’s VEU status must 

be revoked; thus public comments on 

whether to revoke this status are 

unnecessary. 

Additionally, allowing for prior 

public notice and comment on this rule 

may be impracticable and contrary to 

the public interest. The EAR advance 

U.S. national security, foreign policy, 

and economic objectives by ensuring an 

effective export control system. In 

accordance with the pre-set criteria, the 

U.S. Government reviews each VEU and 

its facilities to ensure that exports, 

reexports and transfers (in-country) of 

specified items to these entities are 

consistent with such objectives. 

Accordingly, VEUs and their facilities 

may receive through export, reexport or 

transfer (in-country) items that would 

otherwise require a license and 

transaction-specific review, in part due 

to national security concerns. However, 

the listed facility here is no longer 

eligible to be an Authorized VEU 

facility, and in order to protect national 

security, the restrictions of the EAR 

must be in place as soon as possible. 

Allowing public comments to this rule 

would hinder the ability of BIS to 

enforce the EAR’s restrictions on 

exports without a license to the listed 

facility, and therefore public comment 

on this rule is both impracticable, 

because allowing such comment would 

prevent BIS from undertaking its 

mstockstill on DSKH9S0YB1PROD with RULES

Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Rules and Regulations 67031 

statutory duties, and contrary to the 

public’s national security interests. 

In addition, BIS finds good cause to 

waive the requirement of 5 U.S.C. 

553(d)(3) to delay the effectiveness of 

this regulation, because such a delay is 

contrary to the public’s interest. When 

the U.S. Government has been notified 

of or has identified a material change in 

circumstances that warrants revocation 

or modification of VEU status for an 

end-user or a facility of an end-user, 

there is a need to quickly alert the 

public that the facility is no longer 

authorized as a recipient of items under 

Authorization VEU. Delaying this 

action’s effectiveness could result in 

items that otherwise require licenses 

being exported, reexported or 

transferred (in-country), license-free, to 

an ineligible facility. Accordingly, it 

would be contrary to the public interest 

to delay this rule’s effectiveness. 

No other law requires that a notice of 

proposed rulemaking and an 

opportunity for public comment be 

given for this final rule. Because a 

notice of proposed rulemaking and an 

opportunity for public comment are not 

required to be given for this rule under 

the Administrative Procedure Act or by 

any other law, the analytical 

requirements of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) are 

not applicable and no regulatory 

flexibility analysis has been prepared. 

List of Subjects in 15 CFR Part 748 

Administrative practice and 

procedure, Exports, Reporting and 

recordkeeping requirements. 

■ Accordingly, part 748 of the Export 

Administration Regulations (15 CFR 

parts 730–774) is amended as follows: 

PART 748—[AMENDED] 

■ 1. The authority citation for part 748 

continues to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; E.O. 13026, 61 FR 58767, 

3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 

FR 44025, 3 CFR, 2001 Comp., p. 783; Notice 

of August 12, 2010 (75 FR 50681) (August 16, 

2010). 

■ 2. Supplement No. 7 to part 748 is 

amended by removing ‘‘Cension 

Semiconductor Manufacturing 

Corporation’’ and its address ‘‘(3/F, 8–1 

Kexin Road, Export Processing Zone 

(West Area), Chengdu, China 611731)’’ 

from the list of ‘‘Eligible Destinations’’ 

for ‘‘Validated End-User’’ 

‘‘Semiconductor Manufacturing 

International Corporation’’ in ‘‘China 

(People’s Republic of)’’. 

Dated: October 26, 2010. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2010–27517 Filed 10–29–10; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2010–N–0002] 

Oral Dosage Form New Animal Drugs; 

Domperidone 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

original approval of a new animal drug 

application (NADA) filed by Dechra, 

Ltd. The NADA provides for the 

veterinary prescription use of 

domperidone oral gel for prevention of 

fescue toxicosis in periparturient mares. 

DATES: This rule is effective November 

1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Amy L. Omer, Center for Veterinary 

Medicine (HFV–114), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8336, 

e-mail: amy.omer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Dechra, 

Ltd., Dechra House, Jamage Industrial 

Estate, Talke Pits, Stoke-on-Trent, 

Staffordshire, ST7 1XW, United 

Kingdom, filed NADA 141–314 that 

provides for veterinary prescription use 

of EQUIDONE (domperidone) Gel for 

prevention of fescue toxicosis in 

periparturient mares. The NADA is 

approved as of September 9, 2010, and 

the regulations in 21 CFR part 520 are 

amended by adding § 520.766 to reflect 

the approval. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, between 

9 a.m. and 4 p.m., Monday through 

Friday. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(i)), this 

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of approval. 

The agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 

5 U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Add § 520.766 to read as follows: 

§ 520.766 Domperidone. 

(a) Specifications. Each milliliter of 

gel contains 110 milligrams (mg) 

domperidone. 

(b) Sponsor. See No. 043264 in 

§ 510.600 of this chapter. 

(c) Conditions of use in horses—(1) 

Amount. Administer 0.5 mg per pound 

(mg/lb) (1.1 mg/kilogram (kg)) by mouth 

once daily starting 10 to 15 days prior 

to the expected foaling date. Treatment 

may be continued for up to 5 days after 

foaling if mares are not producing 

adequate milk. 

(2) Indications for use. For prevention 

of fescue toxicosis in periparturient 

mares. 

(3) Limitations. Do not use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

Dated: October 27, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–27524 Filed 10–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

mstockstill on DSKH9S0YB1PROD with RULES